| July 14, 2006 |
| March 23, 2009 |
| September 2006 |
| August 2011 (final data collection date for primary outcome measure) |
| Panic Disorder Severity Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ] |
| Panic Disorder Severity Scale (measured 12 months following the end of treatment) |
| Complete list of historical versions of study NCT00353470 on ClinicalTrials.gov Archive Site |
- Sheehan Disability Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- Clinical Global Impressions Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: Yes ]
- Hamilton Anxiety Rating Scale [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- Anxiety Disorder Sensitivity Index [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- Brief Body Sensitivity Interpretation Questionnaire [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
- Panic-Specific Reflective Function [ Time Frame: Measured at Month 12 post-treatment ] [ Designated as safety issue: No ]
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- Sheehan Disability Scale
- Adolescent Drug Involvement Scale-Superlite
- Clinical Global Impressions Scale
- Hamilton Depression Rating Scale
- Hamilton Anxiety Rating Scale
- Anxiety Disorder Sensitivity Index
- Brief Body Sensitivity Interpretation Questionnaire
- Panic-Specific Reflective (all measured 12 months following the end of treatment)
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| |
| Comparison of Psychotherapy Programs to Treat Panic Disorder |
| Dynamic Treatment vs. CBT for Panic Disorder |
This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder. |
Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD.
Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms. |
| Phase III |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Anxiety Disorders
- Panic Disorder
- Agoraphobia
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- Behavioral: Cognitive behavioral therapy
- Behavioral: Applied relaxation training (ART)
- Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
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- Experimental: Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
- Active Comparator: Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
- Active Comparator: Participants will receive applied relaxation training for 12 weeks
|
- Milrod B, Leon AC, Busch F, Rudden M, Schwalberg M, Clarkin J, Aronson A, Singer M, Turchin W, Klass ET, Graf E, Teres JJ, Shear MK. A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder. Am J Psychiatry. 2007 Feb;164(2):265-72. Erratum in: Am J Psychiatry. 2007 Jul;164(7):1123. Am J Psychiatry. 2007 Mar;164(3):529.
- Milrod BL, Leon AC, Barber JP, Markowitz JC, Graf E. Do comorbid personality disorders moderate panic-focused psychotherapy? An exploratory examination of the American Psychiatric Association practice guideline. J Clin Psychiatry. 2007 Jun;68(6):885-91.
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| |
| Recruiting |
| 233 |
| August 2011 |
| August 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia
- History of at least one spontaneous panic attack per week within the month prior to study entry
Exclusion Criteria:
- Active substance dependence within 6 months prior to study entry
- Lifetime history of any psychotic disorder, including bipolar disorder
- Acutely suicidal
|
| Both |
| 18 Years to 70 Years |
| No |
|
|
| United States |
| |
| NCT00353470 |
| Barbara Milrod, MD, Professor of Psychiatry, Weill Medical College of Cornell University |
| R01 MH070918, R01 MH70664, DSIR 83-ATAS |
| National Institute of Mental Health (NIMH) |
|
| Principal Investigator: |
Barbara Milrod, MD |
Weill Medical College of Cornell University |
|
| Principal Investigator: |
Jacques P. Barber, PhD |
University of Pennsylvania |
|
|
| National Institute of Mental Health (NIMH) |
| March 2009 |